Cleared Traditional

K121991 - ENTEROCOCCUS QUICKFISH BC

K121991 is an FDA 510(k) clearance for ENTEROCOCCUS QUICKFISH BC, manufactured by Advandx, Inc.. The device is a Class 1 Microbiology device with product code OAH cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K121991 · Advandx, Inc. · Microbiology device
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Jan 2013
Decision
185d
Days
Class 1
Risk

K121991 is an FDA 510(k) clearance for the ENTEROCOCCUS QUICKFISH BC. Classified as Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis (product code OAH), Class I - General Controls.

Submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on January 7, 2013 after a review of 185 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Advandx, Inc. devices

FDA 510(k) Submission Details - K121991

510(k) Number K121991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2012
Decision Date January 07, 2013
Days to Decision 185 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 102d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

OAH Device Classification - Class 1, General Controls

Product Code OAH Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
Definition E. Faecalis Pna Fish Is A Qualitative Nucleic Acid Hybridization Assay Intended For The Identification Of Enterococcus Faecalis And Other Enterococci (oe) From Blood Cultures Showing Gram-positive Cocci In Pairs And Chains.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.